Pharmexcil seeks one-time NOC for painkiller

The Pharmaceuticals Export Promotion Council of India (Pharmexcil) has taken up with the Centre's Department of Revenue issue of stocks of Tramadol, a painkiller that was brought under the purview of Narcotic Drugs and Psychotropic Substances (NDPS) Act, 1985, last month and in possession of some of its members.

“Many of the members are having huge stocks that were manufactured/ procured based on export orders and now they are not able to export due to the April 26 notification listing Tramadol as psychotropic drug and bringing it under the purview of NDPS Act. Consequent to the notification, manufacture/ distribution/ export of the drug is strictly monitored as per the rules and regulations,” Pharmexcil said.

Stating this, a Pharmexcil circular detailed guidelines for its members, pertaining to registering with the Narcotic Control Board and the procedures to be followed for manufacture, import, distribution and export of Tramadol.

“Members are advised to follow the procedures strictly, as otherwise the responsible person will have to face criminal prosecution,” the circular said.

“We wish to inform that we have taken up this issue with Department of Revenue, through Ministry of Commerce, requesting them not to seize the stocks and initiate prosecutions with respect to batches manufactured/ procured before April 26, 2018,” Pharmexcil director general Ravi Uday Bhaskar told the members in the circular.

The Council has also requested for one-time NOC for export of this product manufactured before the above date.

Government response

“We are waiting for the government’s response and would share it with the members as soon as we hear from them,” he said.

The circular said members may note that Pharmexcil is only making the efforts and was not sure of government’s decision in this regard.

To avoid any adverse consequences, members were advised to initiate registration with Narcotic Control Board as per the laid down guidelines.